For Research Participants Research FAQs

  • Types of Research
  • Aspects of Research
  • Informed Consent

Types of Research

What is basic research?

A branch of medical research that studies disease at a molecular or cellular level

What is clinical research?

A branch of medical research that engages human volunteers to answer specific health questions.

What is translational research?

A branch of medical research that attempts to more directly connect basic research to patient care. Scientific discoveries typically begin in the laboratory with basic research then progress to the clinical level.

What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness

What are the phases of clinical trials?

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate it safety, determine a safe dosage range, and identify potential side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Aspects of Research

What is the difference between medical care and research?

The main purpose of medical care is to focus on the health and well being of patients. The main purpose of research is to test new scientific ideas or new treatments. Research may help individual participants, but this is not always the case.

Who sponsors clinical research studies?

Clinical research studies are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies, and federal, state or local government agencies.

Who monitors the conduct of protocols?

Physicians, nurses, sponsors, auditors, statisticians and federal and non-federal regulatory bodies, like the Institutional Review Board. This means that different groups are reviewing the safety and progress of each study on a regular basis. If any of these groups determine that there is a concern with how the study is conducted, the study will stop.

What is the role of an Institutional Review Board (IRB)?

All clinical studies must receive approval from an IRB before seeing participants. The IRB's primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. In doing so, the IRB must ensure that the human subject research is conducted ethically, and in compliance with Federal regulations, the requirements of applicable New York State and local law, and institutional policies and procedures. The ethical conduct of research is a shared responsibility. It requires cooperation, collaboration, and trust among the institution, investigators and their research staff, the subjects who enroll in research, and the Institutional Review Board (IRB). You can contact the WCMC IRB at irb@med.cornell.edu.

Who can participate in a clinical research study?

Each research study is different and each tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. The factors that allow someone to participate in a clinical trial are called inclusion criteria and those that disallow someone from participating are called exclusion criteria. Not everyone with the disease or problem that is being studied can take part in a research study. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and to help ensure that researchers will be able to answer the questions they plan to study.

How do I decide whether to participate in a clinical research study?

Choosing to participate in a clinical research study is an important decision. Before participating, you should find out as much as possible about the research study and make sure you understand what happens during the study, the benefits and risks, and any costs to you. Feel free to talk to the research team, your doctor, family members, or friends to determine whether to join a study.

What is informed consent?

Informed consent is a process that helps participants learn about the research study. After learning about the research, participants should understand the following 10 elements of the study:

  1. Purpose
  2. Procedures
  3. Risks
  4. Benefits
  5. Alternatives to Participation
  6. Confidentiality
  7. Compensation for research related injuries
  8. Contact information for question regarding the study
  9. Rights as a research subject
  10. Participation is voluntary

Informed Consent

What are the benefits?

The ongoing partnership between investigators and research participants is one of the foundations of modern healthcare, because clinical research helps set the standards for patient care. Participants in clinical research may play an active role in scientific discoveries, gain access to new research treatments before they are widely available, and/or help others by contributing to knowledge about a particular disease. Participants can also contribute to better understanding of how the treatment works in people of different ethnic backgrounds and genders.

What are the risks?

There may or may not be risks, depending on the particular research study. These risks will be discussed with participants by the research team. There may also be side effects that cannot be predicted. Many side effects go away shortly after the drug/intervention is stopped, but in some cases side effects can be serious, long lasting or permanent.

What are the costs?

In some cases, taking part in a clinical research study will not cost participants or their insurance company anything. In other studies, the research team may bill you or your insurance company for drugs, devices , and the services they provide. Before choosing to participate, the research team will describe any costs in detail.

Do research participants get paid?

Some studies compensate participants for the time they spent participating in a study. Generally this amount is given to cover expenses for parking, transportation, meals, and lost work time.

Can a participant leave a study after it has begun?

Yes. A participant can leave a clinical research study at any time. When withdrawing from the study, the participant should let the research team know about it, and the reasons for leaving the study.

How are research participants protected?

The ethical and legal codes that govern medical practice also apply to clinical research. Physicians, nurses, sponsors, auditors, statisticians and federal and non-federal regulatory bodies carefully monitor the actual conduct and safety of studies. This means that different groups are reviewing the safety and progress of each study on a regular basis. If any of these groups determine that there is a concern with how the study is conducted, the study will stop.

What about confidentiality?

Efforts will be made to protect participants' medical records and other personal information to the extent allowed by law. However, studies cannot guarantee absolute confidentiality. Participants are not identified personally in any reports or publications resulting from a study.